FDA.reportPublic FDA data

Pisces-SA

Primary DI
B06217500601
Brand
Pisces-SA
Company
Osseus Fusion Systems, LLC
Model
1750-0601
Catalog number
1750-0601
Device description
Handle, T-Handle Fixed, 1/4" SQ, Secure Shaft, Impact
Published
2022-05-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213935000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213935000PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems2022-05-06OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B06217500601PrimaryHIBCC0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
933442068
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B06234500010Pisces-SC Standalone Cervical Interbody3450-00103450-00102026-10-29
B06234500020Pisces-SC Standalone Cervical Interbody3450-00203450-00202026-10-29
B06234500030Pisces-SC Standalone Cervical Interbody3450-00303450-00302026-10-29
B06234500040Pisces-SC Standalone Cervical Interbody3450-00403450-00402026-10-29
B06234500050Pisces-SC Standalone Cervical Interbody3450-00503450-00502026-10-29
B06234500052Pisces-SC Standalone Cervical Interbody3450-00523450-00522026-10-29
B06234500053Pisces-SC Standalone Cervical Interbody3450-00533450-00532026-10-29
B06234500054Pisces-SC Standalone Cervical Interbody3450-00543450-00542026-10-29
B06234500061Pisces-SC Standalone Cervical Interbody3450-00613450-00612026-10-29
B06234500062Pisces-SC Standalone Cervical Interbody3450-00623450-00622026-10-29
B06234500063Pisces-SC Standalone Cervical Interbody3450-00633450-00632026-10-29
B06234500064Pisces-SC Standalone Cervical Interbody3450-00643450-00642026-10-29
B06234500070Pisces-SC Standalone Cervical Interbody3450-00703450-00702026-10-29
B06234500071Pisces-SC Standalone Cervical Interbody3450-00713450-00712026-10-29
B06234500080Pisces-SC Standalone Cervical Interbody3450-00803450-00802026-10-29
B06234500081Pisces-SC Standalone Cervical Interbody3450-00813450-00812026-10-29
B06234500090Pisces-SC Standalone Cervical Interbody3450-00903450-00902026-10-29
B06234500100Pisces-SC Standalone Cervical Interbody3450-01003450-01002026-10-29
B06234500110Pisces-SC Standalone Cervical Interbody3450-01103450-01102026-10-29
B06234500121Pisces-SC Standalone Cervical Interbody3450-01213450-01212026-10-29

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08809986489876LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-11-05
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00190776437855MillenniumAvalign Technologies, Inc.LXH2026-11-04
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